PENG Block Variants With Dexamethasone and Dexmedetomidine in Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-100
SponsorPoznan University of Medical Sciences
About this trial
This study will compare three different versions of the Pericapsular Nerve Group (PENG) block in adults aged 65 years and older who are undergoing surgery for hip conditions. The PENG block is a regional anesthesia technique that can reduce pain after surgery and decrease the need for strong opioid pain medications.
All patients in the study will receive the PENG block with 20 mL of 0.2% ropivacaine, but they will be divided into three groups based on the additional medications used:
Group 1: PENG block with ropivacaine plus 4 mg of dexamethasone given intravenously.
Group 2: PENG block with ropivacaine plus 25 micrograms of dexmedetomidine given near the nerves and 4 mg of dexamethasone given intravenously.
Group 3: PENG block with ropivacaine plus 25 micrograms of dexmedetomidine and 4 mg of dexamethasone given near the nerves.
Both dexmedetomidine and dexamethasone are medications that may improve the strength and duration of nerve blocks.
The main goal of this study is to determine which combination provides the best pain control after hip surgery, reduces the need for opioid medications, and improves patient comfort and recovery. We also aim to evaluate the safety and side-effects of each technique.
We hypothesize that adding both dexmedetomidine and dexamethasone near the nerves will provide the longest and most effective pain relief when compared to intravenous administration alone.
This trial may help identify the most effective PENG block formula for older adults undergoing hip surgery and could improve pain management, decrease complications related to opioids, and support faster recovery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 65 years or older
Scheduled for elective or emergency hip surgery (e.g., hip fracture fixation or hip arthroplasty)
ASA physical status I-III
Ability to communicate pain intensity using the NRS scale
Disqualifiers
Patient refusal or inability to provide informed consent
Allergy, intolerance, or contraindication to any study medication: ropivacaine, dexamethasone, dexmedetomidine
Pre-existing neurological deficit or neuropathy of the affected limb
Coagulopathy (INR >1.5, platelets <100,000/µL) or current therapeutic anticoagulation that contraindicates regional anesthesia
Trial design
Design model
Parallel
Treatments tested in this trial
Dexamethasone (intravenous)
DrugPerineural: 20 mL 0.2% ropivacaine + perineural placebo (normal saline) Intravenous: 4 mg dexamethasone + matching volume of saline if needed
Dexamethasone (intravenous) with Dexmedetomidine (perineural)
DrugPerineural: 20 mL 0.2% ropivacaine + 25 µg dexmedetomidine (± saline to equalize volume) Intravenous: 4 mg dexamethasone
Dexamethasone (perineural) with Dexmedetomidine (perineural)
DrugPerineural: 20 mL 0.2% ropivacaine + 25 µg dexmedetomidine + 4 mg dexamethasone Intravenous: placebo (0.9% normal saline)
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: PENG Block With Intravenous DexamethasoneActive comparator 1 intervention
Group B: PENG Block With Perineural Dexmedetomidine and Intravenous DexamethasoneActive comparator 1 intervention
Group C: PENG Block With Perineural Dexmedetomidine and Perineural DexamethasoneExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Time to First Rescue Analgesia
Time (in hours) from the end of the PENG block (completion of local anesthetic injection) to the first administration of rescue analgesia (opioid or non-opioid) given for pain intensity ≥4 on the 0-10 Numerical Rating Scale (NRS). Data will be collected from anesthesia records and postoperative medication charts.
Time frame
Within 48 hours after the end of surgerySecondary outcomes
1
Pain Intensity at Rest (NRS 0-10)
Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.
Time frame
4 hours after surgery2
Pain Intensity at Rest (NRS 0-10)
Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.
Time frame
8 hours after surgery3
Pain Intensity at Rest (NRS 0-10)
Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.
Time frame
12 hours after surgery4
Pain Intensity at Rest (NRS 0-10)
Pain intensity at rest assessed using the 0-10 Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain). Mean NRS scores at each time point will be compared between groups.
Time frame
24 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov